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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 1
| Issue : 2 | Page : 69-75 |
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Glucose level assisted monitoring diet – Impact on diabetes parameters, risk factors, and quality of life
Parimala Jaggesh, Srihari U Surendra
AlaMirap Nutrition, Bangalore, Karnataka, India
| Date of Submission | 16-Mar-2022 |
| Date of Decision | 04-May-2022 |
| Date of Acceptance | 05-May-2022 |
| Date of Web Publication | 16-Jul-2022 |
Correspondence Address:
Parimala Jaggesh
Founder Director, AlaMirap Nutrition, #1, 6th Main 5th Cross Kashi Mutt Road, Malleswaram, Bengaluru - 560 055, Karnataka
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/cdrp.cdrp_1_22
Background: There is an increasing need to revise diabetes management. Two-thirds of patients with diabetes do not have their blood sugar under control. There has been increasing evidence suggesting the positive impact of diet and lifestyle on blood sugar control. This study aims to demonstrate the adoption of the Glucose Level-Assisted Monitoring Diet (GLAM diet) validated by the aid of ambulatory glucose profiling and examine the impact of the GLAM diet on blood glucose concentration, lipid profile, and glucose variability. Methods: In this open-label, interventional pilot study, we enrolled 50 diabetes patients with or without hypertension to receive a GLAM diet, in addition to counseling. The primary outcome was the control and remission of diabetes. The secondary outcome was a composite of optimal maintenance of glucose concentration, optimal lipid profile, glucose variability evaluation, reduced insulin supplementation, diabetes-related complications following the GLAM diet, lifestyle modification, and overall quality of life through indicators such as sleep, stress, and nutrition. Results: GLAM diet significantly reduced Fasting Blood Sugar (FBS) (202 ± 65.47 mg/dL vs. 160.2 ± 37.75 mg/dL, P < 0.001), postprandial blood sugar (PPBS) (246.1 ± 74.74 mg/dL vs. 196.5 ± 45.48 mg/dL, P < 0.001), laboratory glycated-hemoglobin (9.2 ± 1.74% vs. 8.1 ± 1.5%, P < 0.001), and average glucose (182.4 ± 47.54 mg/dL vs. 152.2 ± 39.32 mg/dL, P < 0.001). The glucose remained within target increasing frequently after the diet was implemented (49.7 ± 27.11% vs. 65.6 ± 20.01%, P < 0.001) and although fell just short of statistical significance, there was a percentage decrease in glucose level above target (46.6 ± 29.17% vs. 27.6 ± 22.71%, P = 0.109) observed in the study group. Patients also experienced significantly reduced body weight, body mass index, waist circumference, hip circumference, body fat percentage, and Mean amplitude of glycemic excursions (MAGE), Continuous overall net glycemic action (CONGA), and standard deviation values in comparison to baseline. Conclusion: Patients initiated onto the GLAM diet had better glycemic control, lipid profile, and glucose variability along with enhanced sleep, reduced stress, and improved nutrition understanding in study participants. In conclusion, the GLAM diet apart from reducing glycemic burden also helped to improve the overall quality of life.
Keywords: Blood glucose, blood sugar control, glucose level assisted monitoring diet, glucose variability, glycemic control, lifestyle, nutrition, Type 2 diabetes
How to cite this article:
Jaggesh P, Surendra SU. Glucose level assisted monitoring diet – Impact on diabetes parameters, risk factors, and quality of life. Chron Diabetes Res Pract 2022;1:69-75 |
How to cite this URL:
Jaggesh P, Surendra SU. Glucose level assisted monitoring diet – Impact on diabetes parameters, risk factors, and quality of life. Chron Diabetes Res Pract [serial online] 2022 [cited 2023 Mar 29];1:69-75. Available from: https://cdrpj.org//text.asp?2022/1/2/69/351230 |
| Introduction | |  |
Type 2 diabetes is a chronic, incurable lifestyle disease.[1],[2] It is estimated that the number of persons with diabetes will rise from the current value of about 537 million to 643 million by 2030 worldwide. With an increase in prevalence, there is a subsequent increase in the economic burden associated with the disease and its treatment.[3],[4],[5] On average, an Indian with diabetes consumes 5.56 medications, out of which more than two medication is for the management of diabetes.[6] Despite the intense medication strategies, two-thirds of patients with diabetes tend to have uncontrolled diabetes.[7] This therapeutic lack and mounting evidence of nutritional and exercise favoring glucose control have steered the treatment toward lifestyle modifications.[8] With multiple diet options available claiming to keep blood glucose in check, one might feel overwhelmed choosing the diet for an individual.[9] What if we customize the diet based on glucose response instead? Glucose Level Assisted Monitoring Diet (GLAM diet), a process that makes recommendations based on glucose level readings, has been developed. This process does not include any supplementation, dietary intolerance and can be adapted by all age groups indefinitely. The process involves counseling patients with knowledge on nutrition and disease management to prevent secondary complications.
The aim of the study is to demonstrate the adoption of the GLAM diet validated by the aid of ambulatory glucose profiling (AGP) generated by the Freestyle Libre Pro (FSLP) system and to examine the impact of the GLAM diet on glucose concentration, lipid profile, and glucose variability.
FSLP system is a novel system that provides 1344 glucose level readings through a coin-sized sensor inserted into the outer aspect of the upper arm for the AGP generation. This single-use on-body sensor uses wired enzyme technology (osmium mediator and glucose oxidase enzyme co-immobilized on an electrochemical sensor) to continuously measure the interstitial fluid glucose every 15 min. It has a reader that downloads the data collected by the sensor and proprietary software that uses these data to prepare graphs depicting the mean glucose values as well as glycemic variability at different times of the day during a 14-day monitoring period.[10]
| Methods | | |
Study design and patients
This is an open-label, interventional pilot study conducted for 1 year (August 2018–July 2019). The study was approved by the American Council on Education Independent Ethics Committee and written consent was administered to all patients before enrollment. Patients with established type 2 diabetes mellitus receiving oral hypoglycemic agents and nutritional therapy at NutriAffair were recruited for the study.
Eligibility criteria included the age ranging between 18 and 60 years, established diagnosis of type 2 diabetes on nutritional therapy with or without hypertension. Patients were excluded if they had prediabetes or were on insulin therapy, had type 1 diabetes mellitus, had bariatric surgery, or had a substance abuse history.
Sampling
Participants who met the study criteria and provided consent for study enrollment were recruited as per the investigator's judgment.
Trial procedure
After enrollment, the patient's baseline AGP was monitored along with glycemic response to dietary intake, hip and waist measurements, body mass index (BMI), lipid profile, and blood pressure. Based on the predicted glucose pattern, an individualized diet plan was administered to the patients. The principles of dietary intervention are of two-pronged nature. AGP graphs were used to understand the foods best suited for the individual. Based on which, the diet plan was delivered to prevent any extreme fluctuations in blood glucose and to maintain it in an optimal range of 80–180 mg/dl. No changes were made to the patient's pharmacotherapeutic regimen. Patients were encouraged to do a minimum of 30 min of physical activity a day. Patient-specific guidance was provided in case of physical activity limitations. Glucose levels were monitored and profiled using values generated by the FSLP system (Abbott Diabetes Care).
There were no fixed dietary plans as glycemic response varies vastly among individuals. The diet plan was a plant-based and all-natural diet inclusive of local fruits, grain, and vegetable produce. Simple grains were replaced with readily available complex carbohydrates. The portion sizes were monitored and the patients were individually guided on the healthy plate concept of 25% complex carbohydrates, 25% protein, and 50% fruits and vegetables with a small portion of good fats and dairy products. Food group-wise distribution of macronutrients was not advised in patients as they can be restrictive in nature. No additional supplements were provided for the subjects. The domestic nature of the product would reduce the economic burden on the subject and promote sustained dietary and lifestyle modifications. In addition, patients were counseled on the effects of hypo- and hyperglycemia including ways to minimize such episodes. Patients were also educated on food and their glycemic index values for a sustainable self-management for their long-term health care. Two weeks before the end of 3-month period, AGP and other laboratory values were reevaluated for the second time along with sleep, stress, and understanding levels to assess the effect of the intervention on type 2 diabetes mellitus.
Outcomes
The primary objective was to control and remission of type 2 diabetes through the GLAM diet and lifestyle modification. The secondary objective was a composite of optimal maintenance of glucose concentration, optimal lipid profile, and glucose variability evaluation following the GLAM diet and lifestyle modification and overall quality of life through indicators such as sleep, stress, and nutrition.
Statistical analysis
The collected data were documented in Excel sheet and were analyzed using EPI (Epi Info™, Division of Health Informatics and Surveillance (DHIS), Center for Surveillance, Epidemiology and Laboratory Services (CSELS), USA)/SPSS software (Statistical Package for the Social Sciences), IBM Statistics, USA). The descriptive statistics were examined using the Chi-square test, Student's t-test, and other applicable statistical tests as applicable.
| Results | | |
From August 2018 to July 2019, a total of 50 patients were enrolled in the study. No patients were lost to follow-up [Figure 1]. The patients were predominantly female (n = 33, 66%) and the mean (±standard deviation [SD]) chronological age was 45.4 ± 10.68 years at baseline [Table 1]. Thirty-one patients (62%) had a family history of diabetes and one patient (2%) had diabetic complications. During enrollment, seven patients (14%) had abnormal blood pressure, two patients (4%) had high cholesterol, and four patients (8%) had defective thyroid functions [Figure 2]. | Figure 1: Study subjects' flow diagram. BMI: Body mass index, GLAM: Glucose level assisted monitoring diet, HbA1c: Glycated-hemoglobin, T2D: Diabetes Type II
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Outcomes
GLAM diet significantly reduced body weight (76.8 ± 16.79 kg vs. 73.7 ± 15.65 kg, P < 0.001), BMI (28.9 ± 4.99 kg/m2 vs. 27.6 ± 4.54 kg/m2, P < 0.001), waist circumference (36.5 ± 5.12 inches vs. 34.8 ± 4.84 inches, P < 0.001), hip circumference (41.4 ± 5.59 inches vs. 39.6 ± 5.09 inches, P < 0.001), and body age (60 ± 11.14 inches vs. 55.9 ± 11.14 inches, P < 0.001) compared to the baseline. However, there was no statistical mean difference in a waist-to-hip ratio (0.9 ± 0.09 inches vs. 0.9 ± 0.09 inches, P = 0.533).
There was a significant reduction in body fat percentage (36.5 ± 6.14% vs. 34.3 ± 5.44%, P < 0.001), lean body mass (50.5 ± 9.76% vs. 49.6 ± 9.5%, P < 0.001), visceral fat (14.1 ± 6.29 vs. 12.7 ± 5.39, P < 0.001), low-density lipoprotein (LDL) (115.8 ± 26.84 mg/dL vs. 106.7 ± 24.45 mg/dL, P < 0.001), very LDL (42 ± 17.39 mg/dL vs. 36.5 ± 14.43 mg/dL, P < 0.001), serum triglycerides (196.7 ± 75.42 mg/dL vs. 170.4 ± 57.81 mg/dL, P < 0.001), albumin (4.9 ± 0.42 g/dL vs. 4.7 ± 0.36 g/dL, P < 0.001), and systolic blood pressure (SBP) (131.1 ± 19.52 mmHg vs. 126.3 ± 11.05 mmHg, P = 0.021). Diastolic blood pressure (DBP) (87.8 ± 9.24 mmHg vs. 91 ± 10.18 mmHg, P < 0.001) was found to be uncharacteristically increased. High-density lipoprotein (HDL) (42.8 ± 8.27 mg/dL vs. 43.6 ± 7.42 mg/dL, P < 0.001) and total protein (7.2 ± 0.4 g/dL vs. 6.9 ± 0.42 g/dL, P < 0.001) positively increased in GLAM administered subjects. There was a reduction in total cholesterol (185.8 ± 36.36 mg/dL vs. 170.3 ± 36.51 mg/dL, P = 0.227), although not significant.
There was a significant beneficial decrease in FBS (202 ± 65.47 mg/dL vs. 160.2 ± 37.75 mg/dL, P < 0.001), PPBS (246.1 ± 74.74 mg/dL vs. 196.5 ± 45.48 mg/dL, P < 0.001), estimated glycated-hemoglobin (HbA1c) (8.1 ± 1.6% vs. 6.9 ± 1.36%, P < 0.001), laboratory HbA1c (9.2 ± 1.74% vs. 8.1 ± 1.5%, P < 0.001), and average glucose (182.4 ± 47.54 mg/dL vs. 152.2 ± 39.32 mg/dL, P < 0.001). The glucose remained within target increasing frequently after the diet was implemented (49.7 ± 27.11% vs. 65.6 ± 20.01%, P < 0.001) and although fell just short of statistical significance, there was a percentage decrease in glucose level above target (46.6 ± 29.17% vs. 27.6 ± 22.71%, P = 0.109) observed in the study group [Figure 3]. | Figure 3: Study parameters pre- and postdiet. BMI: Body mass index, FBS: Fasting blood sugar; HbA1c: Glycated-hemoglobin, HDL: High-density lipoprotein, LDL: Low-density lipoprotein, PPBS: Postprandial blood sugar, VLDL: Very-low-density lipoprotein, GLAM: Glucose level assisted monitoring diet
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Glucose fluctuations were also kept under control after diet implementation in comparison to baseline with decrease in MAGE, CONG, and SD values. Their values as follows: MAGE 2nd (118.7 ± 30.54 mg/dL vs. 111.2 ± 23.89 mg/dL, P = 0.246), MAGE 13th (88.3 ± 26.84 mg/dL vs. 82.7 ± 21.63 mg/dL, P < 0.001), CONG 2nd (157.9 ± 59.96 mg/dL vs. 125.6 ± 46.06 mg/dL, P < 0.001), CONG 13th (136.7 ± 45.73 mg/dL vs. 108.1 ± 33.15 mg/dL, P < 0.001), mean 2nd (197.4 ± 64.06 mg/dL vs. 160.2 ± 50.5 mg/dL, P < 0.001), mean 13th (166.9 ± 49.74 mg/dL vs. 136 ± 38.59 mg/dL, P = 0.031), SD 2nd (53.9 ± 16.32 mg/dL vs. 46.3 ± 21.69 mg/dL, P = 0.467), and SD 13th (37.1 ± 14.12 mg/dL vs. 34.9 ± 19.27 mg/dL, P = 0.004) [Table 2] and [Figure 4]. | Figure 4: (a) MAGE, (b) CONG, (c) mean and (d) standard deviation box plot
Click here to view |
Sleep conditions significantly improved in the study population; 80% of patients experienced regular sleep compared to 46% before diet (disturbed: 16% vs. 46%, moderate: 8% vs. 4%, and regular: 80% vs. 46%, P = 0.002) [Table 3]. All patients had optimal understanding of nutrition by the end of the study [Table 4]. No single patient in the study demonstrated high levels of stress postintervention, which is a significant reduction from 28% prediet (low stress: 58% vs. 16%, moderate stress: 42% vs. 56%, and high stress: 0.0% vs. 28%, P = 0.123) [Table 5].
| Discussion | | |
In this open-label, interventional study involving patients with type 2 diabetes, favorable results were observed in glucose concentration, lipid profile, and glucose variability after the implementation of GLAM diet. In addition, the subjects also demonstrated enhanced sleep pattern, reduced stress level, and increased understanding of nutrition.
This study has a number of strengths. GLAM is an all-inclusive diet that does not exclude any specific food groups such as the ones that restrain starch or carbohydrate, and it is a nonextreme diet in comparison to diet that mimics fasting or has a meal replacement. This is the first literature on glucose level assisted monitoring focusing on the Indian population. The said diet produced significant results despite only being administered for 3 months.
Dietary management approaches for improved glycemic control in patients with type 2 diabetes may depend on the use of diets with a low-glycemic index instead of using a standard low-fat diet. A randomized study by Pavithran et al., conducted among 40 Indian patients on low-glycemic index South Indian for 6 months demonstrated similar HbA1c reduction of 0.8% compared to 1.1% in our study.[11] Another randomized control trial by Tang and Lin administered fasting-mimicking diet and specific meal replacement in 100 patients with type 2 diabetes and concluded a similar mean HbA1c (1.36% vs. 1.1%) and fasting blood glucose reduction (41.58 mg/dL vs. 41.8 mg/dL). However, the mean fasting blood glucose was lower in this study (88.92 mg/dL) compared to our study (49.6 mg/dL) which could be easily accounted by intense restriction in patient's diet. This diet also displayed superior blood pressure and lipid control with the following mean difference values SBP (−14.18 mmHg vs. −4.8 mmHg), DBP (−10.98 mmHg vs. +3.2 mmHg), STG (−31.5 mg/dL vs. −26.3 mg/dL), TC (−50.04 mg/dL vs. −15.4 mg/dL), HDL (+18.9 mg/dL vs. +0.7 mg/dL), and LDL (−33.48 mg/dL vs. −9.1 mg/dL).[12]
Our study has some important limitations. First, our sample size was small. There is no control group to compare the study group results with. However, the limited sample size enabled the investigator to better focus on the patient's behavior, monitoring, and outcome. Another one is the application of the intervention – considering the socioeconomic status of the Indian population.
| Conclusion | | |
This study examined the effectiveness of GLAM diet in patients with type 2 diabetes. After counseling and administering the diet for 3 months in total 50 patients, the values suggest that the diet had better glycemic control, lipid profile, and glucose variability. In addition to glycemic benefits, there were also positive effects on quality of life indicators such as sleep, stress, and nutrition. Further randomized control investigations on larger samples are needed to establish the benefit of GLAM diet in type 2 diabetes control and remission.
Acknowledgment
The author would like to thank the patients enrolled in this study and their families. The author would also like to thank team ARFECT for providing assistance in medical writing for the manuscript. The author acknowledges the sponsorship by Abbott Healthcare private Ltd (Abbott Diabetes Care) toward medical writing fees for team ARFECT.
Financial support and sponsorship
Medical writing charges were paid for by Abbott Healthcare Pvt Ltd (Abbott Diabetes Care). The authors received no honoraria from Abbott Diabetes Care directly or indirectly related to the development of this publication.
Conflicts of interest
Abbott's Freestyle Libre Pro system was used for the study investigation. The author, however, did not receive any research funding from Abbott, nor was the device funded by them. Abbott supported the medical writing of this manuscript through the sponsorship of third-party agency ARFECT.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]
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